The intervention is a 6-session group-based and manualized intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

Behavioral: HIV prevention intervention

The 6-session HIV prevention intervention curriculum, "LifeSkills," incorporates interactive activities, in-depth discussions, videos, games, and role-plays to help young transgender women develop, practice, and integrate new skills into "real-life" situations. Activities address each aspect our theoretical framework (information, motivation, behavior), including experiences that may pre-dispose young transgender women to HIV/STI risk. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

Active Comparator: Diet and nutrition

The comparison condition is a 6-session group-based and manualized health promotion intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

Behavioral: Diet and Nutrition

The comparison condition is a 6-session group-based and manualized health promotion intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

No Intervention: Standard-of-care

This arm will receive HIV and STI testing and counseling only.

Detailed Description:

The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or transmission. The study will test this intervention in a three-arm randomized controlled trial in two major U.S. cities with excellent access to and research experience with the population (Chicago, Boston). We will enroll 375 at risk YTW, ages 16-29; two-fifths of the sample (N=150) randomized to the intervention will participate in the 6-session group-based and manualized Life Skills intervention; two-fifths (N=150) will be randomized to the standard-of-care (SOC) control condition; and one-fifth will be randomized to the time-matched attention control condition (N=75) and receive standard health promotion information in a group-based multi-session format. All three arms will receive HIV and sexually transmitted infection (STI) (Chlamydia and gonorrhea) testing and pre-posttest risk reduction counseling (i.e., SOC). Sexual risk will be assessed at baseline, 4, 8 and 12 months post-intervention Our specific aims are: 1) to determine the efficacy of the Life Skills intervention in comparison to a SOC arm and a time-matched attention control on the primary outcome: number of unprotected anal sex acts (UAS) (in the previous four months) among YTW, ages 16-29; and 2) to examine the degree to which improvements in sexual risk taking are mediated by the conceptual mediators of the intervention: transgender adaptation and integration, collective self-esteem/empowerment, information (HIV knowledge), motivation (attitudes, norms, and intentions for safer sex), and behavioral skills (discussing sex and condom use with sexual partners, acquiring and using condoms); and to explore whether reductions in sexual risk are associated with epidemiologically-linked moderators of sexual risk behavior: age, race/ethnicity, and psychosocial factors. An additional exploratory aim is to describe the prevalence of HIV and STIs in the community recruited sample; in the SOC arm, we will assess the natural trajectory of sexual risk behavior and the acquisition of HIV and STIs (incidence rate) in YTW over a 12-month follow-up period.

Eligibility

Ages Eligible for Study:

16 Years to 29 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

age 16-29

self-identified as transgender, transsexual, and/or female with a male biological or birth sex

self-reported history of unprotected anal or vaginal intercourse, anal or vaginal sex with more than one sexual partner, anal or vaginal sex in exchange for money, food, shelter, or diagnosis with HIV or another STI in the previous 4 months

able to speak and understand English

willing and able to provide informed consent/assent

intention to reside in the local area throughout the 12 month follow-up period

Exclusion Criteria:

unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview

active suicidal ideation at the time of baseline interview

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575938